Renal Denervation in Patients With Uncontrolled Blood Pressure

Exclusion Criteria

• •1. Inability to sign written informed consent.
• •2. Individual has renal artery anatomy that is ineligible for treatment including:
• •1. Main renal arteries with \<20 mm treatable length
• •2. Renal artery stenosis of ≥20% by angiography.
• •3. A history of prior renal artery intervention including balloon angioplasty or stenting.
• •4. Multiple main renal arteries in either kidney.
• •3. Individual has an eGFR of \< 45mL/min/1.73m2, using the MDRD formula calculation.
• •4. Individual has had \>1 hospital admission for a hypertensive crisis within the past year.
• •5. Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP\<135mmHg.
• •6. Individual has has \> 1 episode(s) of orthostatic hypotension (reduction of SBP of \>20 mmHg or diastolic blood pressure (DBP) of \>10 mmHg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process.
• •7. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• •8. Individual has primary pulmonary hypertension.
• •9. Individual has scheduled or planned surgery or cardiovascular intervention in the next 3 months.
• •10. Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
• •11. Individual is pregnant, nursing or planning to be pregnant.
• •12. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
• •13. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
• •14. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
• •15. Individual is currently enrolled in another investigational drug or device trial.